Tuesday, June 05, 2007

The Matthew Holford Rant - 'Efficacy'

I've been tooling around, for the past couple of months, trying to establish an understanding of the legislative framework, as it pertains to the trial and licensing of drugs. I've also been trying to establish how it is that the MHRA implements this legislation, within its regulatory framework (it doesn't appear to have one - it's got no written procedures, anyway, or so it tells me). It grieves me greatly to report that I seem to have stumbled upon another area pertaining to the administration of services to the public, which is less than clear and open to abuse, by the looks of things. This other area being the Freedom of Information Act ("FOIA"), which is the piece of legislation that permits mugs like me to seek information from public bodies. A little background is in order, I think.

Now, there are a whole bunch of different exemptions, which a public authority may implement, in order to avoid giving information, under the FOIA. I'm not familiar with the full list, but it includes such things as compliance with the Data Protection Act, a cash limit (£600 (24 hours at £25 an hour) during any 2-month (I think) period), and vexatious requests. However, we have a grey area, it seems. The MHRA (along with the ABPI, Glaxo SmithKline and the Department of Health) has consistently failed to address a question that I have put repeatedly in various guises, over the past couple of months: "what is the benefit of Seroxat?". It has not expressly refused to do so, which would presumably permit me to complain formally, under the FOIA (there is a complaints procedure). At the moment, I am trying to ascertain how the Information Commissioner's Office views selective or complete ignorance, on the part of a public authority. Actually, given that the Act is worthless, if public bodies are permitted to stonewall, I've also asked to whom one should apply, where an authority has not implemented an exemption, but merely declines to answer.

Back to the point, and just to reiterate, Seroxat absolutely must have a benefit, because otherwise the MCA (the MHRA's predecessor) would not have been able to conduct a risk:benefit analysis, which is a key component of the assessment process (indeed, the relevant legislation demands that efficacy, safety and quality be evidenced in the licensing portfolio, submitted in support of the marketing authorization application). Once the benefit has been established, one then assesses the risks and judges whether these outweigh the benefit, which one has already established. In assessing this balance, one considers the seriousness of the condition being treated - to take a ridiculous example, one would not accept a treatment for the common cold, if it had fatal side effects, but a cancer treatment that occasionally caused death might be acceptable, presumably, given that cancer may lead to death, anyway. If the risks outweigh the benefit, then the drug will not make it onto the market, in theory. I see a lot of discussion about risks, and how risks are constantly reviewed, but I see no mention of the benefit.

Moreover, when pursued on this question, all the interested parties go quiet. This does nothing to encourage my trust in the process, nor the transparency of the parties involved, despite protestations as to the service being offered. On the contrary, it encourages me to consider the possibility that the whole thing is a fraud, particularly given the clinical views on offer elsewhere. At the moment, I'm waiting for the ICO to come back to me, to advise if it can intervene, and compel the MHRA to respond.